Events

TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Inovanz Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-01358-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01358-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    It has been identified that the frax adjusted for tbs values are not correct when the frax feature is activated in tbs insight and tbs has been computed from a spine scan where some vertebrae were excluded. this does not affect the trabecular bone scores. patient fracture risk evaluations could be altered based on this issue.
  • 조치
    Inovanz has advised users of a new software version, v.3.0.2, that is available and incorporates a permanent fix for this issue. In the interim, Inovanz has advised users to immediately deactivate the FRAX adjusted for TBS feature. In addition, a tool is being provided that will automatically analyse and provide a detailed report for all erroneous fracture risk evaluations with v.3.0.1. This action has been closed-out on 24/05/2017.

Device

TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)
  • 모델명 / 제조번호(시리얼번호)
    TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk)ARTG Number: 227987
  • Manufacturer
    Inovanz Pty Ltd

Manufacturer

Inovanz Pty Ltd
  • Source
    DHTGA